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    Summary
    EudraCT Number:2014-004267-20
    Sponsor's Protocol Code Number:RIG-P000814
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-004267-20
    A.3Full title of the trial
    Multicenter, randomized Phase 2 Trial to determine the Response Rate of Ruxolitinib and Best Available Treatment (BAT) versus BAT in Steroid-refractory acute Graft-versus-Host Disease (aGvHD)
    Multizentrische, randomisierte Phase 2 Studie zur Wirksamkeit von Ruxolitinib und bester verfügbarer Therapie im Vergleich zu bester verfügbarer Therapie alleine bei der Steroid-refraktären akuten Graft-versus-Host Erkrankung (aGvHD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, randomized Phase 2 Trial to determine the Response Rate of Ruxolitinib and Best Available Treatment (BAT) versus BAT in Steroid-refractory acute Graft-versus-Host Disease (aGvHD)
    Multizentrische, randomisierte Phase 2 Studie zur Wirksamkeit von Ruxolitinib und bester verfügbarer Therapie im Vergleich zu bester verfügbarer Therapie alleine bei der Steroid-refraktären akuten Graft-versus-Host Erkrankung (aGvHD)
    A.3.2Name or abbreviated title of the trial where available
    RIG
    A.4.1Sponsor's protocol code numberRIG-P000814
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02396628
    A.5.4Other Identifiers
    Name:DRKSNumber:DRKS00007939
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical Center - University of Freiburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity of Freiburg, Medical Faculty
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportDeutsche Krebshilfe
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportGemeinsamer Bundesausschuss
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Center - University of Freiburg
    B.5.2Functional name of contact pointProf. Dr. Nikolas von Bubnoff
    B.5.3 Address:
    B.5.3.1Street AddressHugstetter Str. 55
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79110
    B.5.3.4CountryGermany
    B.5.6E-mailnikolas.bubnoff@uniklinik-freiburg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Jakavi® 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRuxolitinib
    D.3.9.2Current sponsor codeRuxolitinib
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Jakavi® 15mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRuxolitinib
    D.3.9.2Current sponsor codeRuxolitinib
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Jakavi® 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRuxolitinib
    D.3.9.2Current sponsor codeRuxolitinib
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Jakavi® 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRuxolitinib
    D.3.9.2Current sponsor codeRuxolitinib
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Steroid-refractory acute Graft-versus-Host Disease (GvHD)
    Steroid-refraktäre akute Graft-versus-Host Erkrankung (GvHD)
    E.1.1.1Medical condition in easily understood language
    Steroid-refractory acute Graft-versus-Host Disease (GvHD)
    Steroid-refraktäre akute Graft-versus-Host Erkrankung (GvHD)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018799
    E.1.2Term GVHD
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate efficacy of Ruxolitinib/BAT as compared to BAT alone at day 28 after randomization.
    E.2.2Secondary objectives of the trial
    Overall response rate (ORR:CR+PR) at day 14
    Proportion of patients with durable response to treatment, persisting for at least 4 consecutive weeks within 8 weeks after randomization
    Time to treatment response
    Proportion of patients with treatment failure
    Response duration
    Overall survival (OS)
    Event-free survival (EFS)
    Non Relapse Mortality (NRM)
    Failure-free survival (FFS)
    Steroid tapering failure rate
    Ruxolitinib discontinuation rate (≥ 4 weeks)
    Discontinuation rate of steroid therapy for GvHD
    Response rates (PR and CR) after cross over from BAT alone to BAT and Ruxolitinib
    Cumulative steroid dose until day 56
    Reduction of GvHD blood biomarker rate
    Graft failure rates
    Quality of life (EORTC QLQ-C30 and QLQ-HDC29)
    Rates and severity of chronic GvHD over time
    Duration of inpatient stay
    Frequency of adverse events, engraftment, infections.
    Frequency of CMV reactivation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Acute skin, intestinal (histologically confirmed) or liver GvHD > grade 1 according to standard criteria
    2. Age >=18 years
    3. Failure of previous treatment, defined as presence of at least one of the following criteria:
    3a. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment
    3b. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment
    3c. Failure to taper the prednisone/prednisolone to 0.6 mg/kg/day or methylprednisolone dose to <0.5 mg/kg/day
    4. Written informed consent
    5. Ability to understand the nature of the study and the study related procedures and to comply with them
    E.4Principal exclusion criteria
    1. Uncontrolled underlying disease
    2. Active bleeding
    3. Absence of clinical signs of acute GvHD
    4. Diagnostic or distinctive clinical signs of chronic GvHD
    5. Uncontrolled bacterial, viral or fungal infection
    6. Absolute neutrophil count <0.5 x103/µl
    7. Evidence of transplant-associated microangiopathy (TAM)
    8. Any previous JAK2 inhibitor treatment prior to study enrolment, except Ruxolitinib given prior to the allogeneic stem cell transplantation
    9. Known Hypersensitivity to Ruxolitinib or any of the excipients
    10. Known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening.
    11. Female patients who are pregnant or breast feeding
    12. Concomitant use of any other investigational drug within the last thirty days before the start of this study
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) at day 28 is defined as proportion of patients in each arm demonstrat-ing PR or CR without requirement for additional systemic IST at day 28 after randomization, as compared to time of randomization (Visit 1, day 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28 after randomization
    E.5.2Secondary end point(s)
    Efficacy:
    Overall response rate (ORR) at day 14 is defined as proportion of patients in each arm demonstrating PR or CR without requirement for additional systemic IST at day 14 after randomization.
    Proportion of patients in each arm who achieve a CR or PR without requirement for additional systemic IST, persisting for at least 4 consecutive weeks within 8 weeks after randomization.
    Time to response is defined as time from randomization to the date of first documentation PR or CR.
    Death or relapse/progression of underlying hematologic disease without prior response will be considered to be a competing event. Comparison of treatment arms is conducted until day 28 only, as crossover to Ruxolitinib is offered to non-responders then.
    Rate of patients with treatment failure until day 28 after randomization.
    The duration of response is assessed for responders only by calculating the time from first response to the date of first observation of aGvHD relapse/progression or the date of additional IST for GvHD.
    Onset of chronic GvHD or death without prior observation of aGvHD relapse or progression is considered to be a competing events, and observations where neither occurred are treated as censored observations.
    OS is defined as time from randomization to the date of death from any cause.
    EFS is defined as the time from randomization to the date of recurrence of underlying hematologic disease, graft failure or death due to any cause
    NRM is defined as the time from randomization to the date of death not preceded by hematologic disease recurrence.
    Hematologic disease recurrence / progression is considered to be a competing event.
    FFS is defined as the time from randomization to recurrence of underlying hematologic disease, graft failure, non-relapse mortality (NRM) or addition of new systemic IST for GvHD.
    Onset of cGvHD is considered as a competing event.
    Rate of patients in whom failure to taper steroids below methylprednisolone dose of 0.5 mg/kg/day (or equivalent <0.6 mg/kg/day of predni-sone/prednisolone) was observed within 56 days after randomization OR addition of any new IST for GvHD due to failure to taper steroids below methylprednisolone dose of 0.5 mg/kg/day (or equivalent <0.6 mg/kg/day of prednisone/prednisolone)
    Rate of patients discontinued Ruxolitinib treatment for at least 4 weeks.
    Discontinuation rate of steroid therapy for at least 4 weeks.
    Overall response rate (ORR) at day 14 in this group is defined as proportion of patients demonstrating PR or CR without requirement for additional systemic IST at day 14 after date of cross over from BAT alone to Ruxolitinib/BAT.
    Overall response rate (ORR) at day 28 in this group is defined as proportion of patients demonstrating PR or CR without requirement for additional systemic IST at day 28 after date of cross over from BAT alone to Ruxolitinib/BAT.
    Proportion of patients who achieve a CR or PR without requirement for additional systemic IST, persisting for at least 4 consecutive weeks within 8 weeks after the date of cross over from BAT only to Ruxolitinib/BAT.
    Cumulative steroid dose until day 56 will be calculated.
    Reduction of GvHD blood biomarkers (see section definitions) on day 8 randomization.
    For the calculation of relapse incidence rates, time from randomization to the date of relapse diagnosis will be calculated.
    Death without prior relapse will be considered as a competing event.

    For the calculation of graft failure incidence rates, time from randomization to the date of graft failure diagnosis will be calculated.
    Death without prior graft failure will be considered as a competing event.
    EORTC QLQ-C30 and EORTC QLQ-C29.
    Time from randomization to the start date of any chronic GvHD.
    Hematologic relapse/progression and death without prior chronic GvHD will be considered as competing events.

    Safety:
    Type, frequency, severity and relationship of adverse events to investigational product, engraftment, infections.
    Frequency of CMV reactivation.
    Number of nights in hospital.
    E.5.2.1Timepoint(s) of evaluation of this end point
    different time points, e.g. 14 days, 4 weeks, day 56, continuing between randomisation and end of study (for more details see protocol flow chart)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    best available treatment according DGHO-Onkopedia guidelines (March 2018)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None (further treatment according normal treatment of GvHD)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-08
    P. End of Trial
    P.End of Trial StatusOngoing
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